Learning Through Play (LTP) Plus Intervention for Depressed Fathers (LTP Plus Dads) (LTP+Dads)

Pakistan Institute of Living and Learning

Status: Completed

Conditions: Depression

Treatments: Behavioral: LTP Plus

Study type: Interventional

Funder types: Other

Identifiers

NCT03564847

PILL-LTP Plus Dads-002

Details and patient eligibility

About

The aim of the study is to evaluate the clinical and cost effectiveness of culturally adapted group parenting intervention delivered by non-specialists and community health workers for depressed fathers.

Full description

Most research on the association between parental depression and child outcomes has focused mainly on mothers. However, studies suggest that the relationship between parental depression and child outcome is not necessarily limited to mothers.

The study has two phases quantitative and qualitative:

Purpose of this quantitative phase is to determine if the LTP plus programme delivered by non-specialists and community health workers reduces symptoms of paternal depression and improves child development compared to treatment as usual.

In the qualitative part of the study focus groups and in-depth digitally recorded interviews will be conducted with participants by trained research staff at two-time points both before and after the intervention. These focus groups and in-depth interviews will continue till the data saturation is achieved. In addition, Participants who refused to participate in the trial will be asked if they would be willing to be contacted by a researcher to discuss their reasons for not taking part. Moreover, in-depth digitally-recorded interviews with stakeholders (grandparents, therapists, health professionals, etc) will also be conducted by trained researchers.

Enrollment: 357 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 to 55 years old fathers
• Having children aged between 0-30 months
• Diagnosis of major depressive disorder using the Structure Clinical Interview for DSM-V,
• Ability to complete a baseline assessment.
• Given written informed consent

Exclusion criteria

• Any medical illness that will prevent them from participation in the clinical trial,
• Current or past diagnosis of bipolar depression
• Currently using antidepressants or receiving any kind of psychotherapy
• Active suicidal ideation,
• Any other severe physical or mental disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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357 participants in 2 patient groups

LTP Plus

Experimental group

Description:

LTP Plus Participants will receive the intervention over 4 months Weekly sessions for 2 months and fortnightly for next two months by trained non-specialists/community health workers.

Treatment:

Behavioral: LTP Plus

Treatment As Usual (TAU)

No Intervention group

Description:

Treatment as Usual (TAU) group will receive routine care and their follow up will be done at 4th and 6th month post randomization.